CN109342713A - A kind of Quality Control substance for lipids detection - Google Patents
A kind of Quality Control substance for lipids detection Download PDFInfo
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Abstract
This application discloses a kind of Quality Control substances for lipids detection.Specifically; a kind of composition is disclosed, it includes serum matrix, protective agent, preservative, total cholesterol, triglycerides, high-density lipoprotein cholesterol, low density lipoprotein cholesterol, Apolipoprotein A1, apolipoprotein B, lipoprotein (a), optional apo E, optional phosphatide, optional homocysteine, optional c reactive protein, optional sdLDL-Cs.The application further relates to purposes of this combination in preparation Quality Control substance.According to the Quality Control substance of the application have excellent bottle between bottle uniformity, maintain good stability.
Description
Technical field
This application involves clinical examination fields.More specifically, this application involves used in detection project each in lipids detection
Quality Control substance.
Background technique
Lipid determination is of great significance not only for the diagnosis of hyperlipidemia and the assessment of risks of coronary heart disease and prevention and treatment, and
And research (Yan Shengkai, the Chen Wenxiang of other many clinically relevant professional diseases have been applied to it；Chinese Journal of Cardiology 2004
Year November the o. 11th of volume 32).
The methodology of lipid determination and standardization are also a problem being widely noticed at present.Chinese Medical Association examines branch
For clinical serum total cholesterol (CHO), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein gallbladder
The measuring method formulation of sterol (LDL-C), Apolipoprotein A1, apolipoprotein B and lipoprotein (a) has been delivered " about clinical blood lipid
The suggestion of measurement " file, guarantee the accuracy of measurement result and rationally using important in inhibiting (Chen Wenxiang etc.；Clinical examination
Magnitude tracing problem；Chinese laboratory medicine magazine 2003,26:153-158).
Quality-control product (also making Quality Control substance) refer to clinical biochemical detection use process in detection system carry out hold and
A kind of quality control substance matter (being divided into definite value and non-setting control substance) of control.The purpose of quality-control product is to evaluate or verify to survey
The precision of amount, the accuracy of measurement, due to issuable analysis deviation of the change detecting system of reagent or analysis instrument etc.
Performance characteristic.Quality-control product can also be used in proficiency testing, quality control in laboratory.As it can be seen that quality-control product is non-used in the clinic
Often extensively.Such as: in the analysis quality control procedure of clinical biochemical, the periodic calibration of instrument (such as Biochemical Analyzer etc.),
New instrument installation, reagent, the Internal Quality Control of replacement different batches etc. require to use quality-control product in operating.
The reliability of clinical detection result and the quality of Quality Control substance are closely related, and good Quality Control substance usually has following
Aspect:
(1) good stability
Two aspect of analysis of stability of Quality Control substance, one is that long-time stability (determine the effect of each batch of Quality Control substance
Phase), the other is (redissolution/corkage stability can guarantee that well every bottle of Quality Control substance is utmostly answered to redissolution/corkage stability
With).
(2) uniformity is good
The purpose that quality control is done in laboratory is to reflect the state of detection system, and the laboratory variation of routine testing then includes
Variation between the variation and Quality Control substance bottle of detection system.Therefore only allow uniformity between Quality Control Wu Zhi bottle good, it could really
Embody the truth of detection system.Each laboratory should be paid attention to before redissolving, redissolve when using the Quality Control substance of freeze-drying
Each link after redissolving is neutralized, to ensure Quality Control substance reliability in use.
(3) concentration level of Quality Control substance
Medical science decision level has important clinical meaning, therefore the detection system in laboratory is attached in medical science decision level value
It can closely detect accurate most important.In general, Quality Control substance includes the Quality Control substance of concentration at high level and low value.
(4) plyability
In order to simplify laboratory Quality Control substance classes and reduce the storage cost of Quality Control substance, multiple detection projects are closed
And.Meanwhile compound Quality Control substance also contributes to promoting working efficiency.Compound Quality Control substance is due to complicated component, it is desirable that each component
Between do not interfere with each other.
According to quality control requirement, the ingredient and base of used its ingredient of Quality Control substance and matrix effect and tested sample
Matter is closer to more ideal.Ideally directly use the similar sample of tested sample.However, human serum/blood plasma it is not easy to maintain,
Transport, it is difficult to meet the durability requirements of Quality Control substance.
Therefore, (CN103472240A) discloses a kind of people's blood lipid (serum/plasma) quality management reference in the prior art
Kit contains human serum (blood plasma) matrix, humanized's lipid composition, systems stabilisation and anti-corrosion system in the kit
System.Humanized's lipid composition is humanized's Apolipoprotein A1 antigen (APO A1), apolipoprotein B antigen (APO B), high
Density lipoprotein-cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), lipoprotein a (LP (a)), total cholesterol
(CHO) any one and in triglyceride (TG) or combination.The systems stabilisation is by 0.01%-0.1%
TritonX100,0.005%-0.05%Tween20,5 μm of ol/l-50 μm of ol/l EDTA, 0.01%-0.1% polyvinyl alcohol,
0.05%-0.5% polyvinylpyrrolidone, 0.005%-0.05% Macrogol 6000 composition.The corrosion protection system is
0.02%-0.1% Sodium azide, 0.3-1.2mg/l gentamicin, 0.3-1.2mg/l anphotericin, 0.1%-1%ProClin system
Any one in column or combination.
Technical staff it should be noted that introduced in the technical solution of CN103472240A up to 10 kinds stabilizations and anti-corrosion at
Point (TritonX100, Tween20, EDTA, polyvinyl alcohol, polyvinylpyrrolidone, Macrogol 6000, Sodium azide, celebrating are big mould
Element, anphotericin, ProClin).In the production process of Quality Control substance, the ingredient of introducing is more, and cost is higher, operation is more multiple
Miscellaneous and matrix effect may be bigger.In addition, it is the state in order to reflect detection system that the first purpose that quality controls is done in laboratory,
The laboratory coefficient of variation (CV) contain detection system CV and Quality Control substance C V (between bottle, in bottle, batch between, batch in).As it can be seen that drawing
The ingredient entered is more, and manual operation step is more, then the easier matrix effect for increasing Quality Control substance.This matter for laboratory
Amount control is unfavorable.However, reducing the stabilization introduced and anti-corrosion composition, and the stability of Quality Control substance can be reduced.
In consideration of it, need to find an equalization point, so that Quality Control substance uniformity can be improved and reach satisfied steady
Qualitative requirement.For this purpose, there is still a need for obtain a kind of composition for being suitable as Quality Control substance to those skilled in the art.
Summary of the invention
According to some embodiments, a kind of composition is provided, it includes serum matrix and pharmaceutical acceptable carrier.
According to other embodiments, a kind of composition is provided, is made of serum matrix and pharmaceutical acceptable carrier.
According to some embodiments, a kind of composition is provided, it includes serum matrix and pharmaceutical acceptable carrier, wherein can medicine
It include protective agent and preservative with carrier.
According to other embodiments, a kind of composition is provided, it includes serum matrix and pharmaceutical acceptable carrier, wherein can
Pharmaceutical carrier is made of protective agent and preservative.
According to some embodiments, a kind of composition is provided, it includes serum matrix and pharmaceutical acceptable carrier, wherein can medicine
It is made of with carrier protective agent and preservative, and wherein:
In some embodiments, the composition does not include polyethylene glycol and Triton-X100.
According to other embodiments, a kind of composition is provided, it includes serum matrix and pharmaceutical acceptable carrier, wherein can
Pharmaceutical carrier is made of protective agent and preservative, and wherein:
In some embodiments, the composition does not include polyethylene glycol and Triton-X100.
In some embodiments, protective agent is selected from the following a kind of or combination: sucrose, trehalose, BSA, EDETATE SODIUM,
Glycine.In preferred embodiments, protectant type is reduced as far as possible.
In some embodiments, protective agent is selected from the following a kind of or combines: sucrose, trehalose, BSA.
In some embodiments, preservative is selected from the following a kind of or combination: Sodium azide, Benzylpenicillin sodium salt, nystatin,
Gentamicin, proclin 300.In preferred embodiments, the type of preservative is reduced as far as possible.In some embodiments
In, preservative is selected from the following a kind of or combines: Sodium azide, Benzylpenicillin sodium salt.
In some embodiments, the serum matrix is originated from people.
In some embodiments, the serum matrix is presented any one of selected from the following or is combined: HIV1 negative antibody,
HIV2 negative antibody, Hepatitis B Surface antigen feminine gender, hepatitis C virus negative antibody.
In some embodiments, it is negative refer to determinand there are levels can't detect by detection method used；
It is of course also possible to be to be completely absent.
In some embodiments, detecting HIV1 antibody, HIV2 antibody, Hepatitis B Surface antigen and hepatitis C virus antibody is
No is feminine gender, is considering for biological safety, has no direct correlation with technical effect expected from technical scheme.
In some embodiments, a kind of composition of dry powder form is provided, the group of aforementioned liquids form is corresponded to
Close object.In specific embodiments, the composition of dry powder form is prepared by the composition of liquid form.Specific real
It applies in scheme, dry powder is freeze-dried powder.
In some embodiments, the water content of the freeze-dried powder is no more than 5%；Preferably more than 3%；Do not surpass more preferably
Cross 2%；Most preferably not more than 1.7%.
In the application of this field, medical science decision level has important clinical meaning, therefore the detection system in laboratory
It can be detected near medical science decision level value accurate most important.In consideration of it, Quality Control substance usually require that and cover it is (but unlimited
In) at high level near concentration and low value near concentration.
In the context of this application, aforementioned composition is known as " low value ", is for " high level ".Aforementioned composition
Referred to as " high level " is for " low value ".
When all composition each falls within the range of each of the following in the composition according to the application (containing end value), as referred to as
For low value:
When all composition each falls within the range of each of the following in the composition according to the application (containing end value), as referred to as
For high level:
According to a kind of kit/reagent set in some embodiments, is also provided, it includes composition above-mentioned, liquid
Or dry powder.
According in some embodiments, also offer aforementioned composition is preparing the purposes in Quality Control substance.In some implementations
In scheme, the Quality Control substance is the Quality Control substance for lipids detection.In clinical lipids detection, object to be checked includes at least gallbladder
Sterol, triglycerides, high-density lipoprotein cholesterol, low density lipoprotein cholesterol, Apolipoprotein A1, apolipoprotein B, rouge egg
White (a).Optional object to be checked includes apo E, phosphatide, homocysteine, hs-CRP, small and dense low-density
Lipoprotein cholesterol.
The Quality Control substance of the application is suitable for full-automatic, semi-automatic biochemical analyzer, is including but not limited to applicable in Hitachi's (example
Such as Hitachi7080/7180, HITACHI LABOSPECT008AS), Beckman (such as BECKMAN COULTER AU400/
AU680/AU5800), Abbott Laboratories (such as ARCHITECTc4000/c8000/c16000), Siemens (such as ADVIA2400), Toshiba
The various existing or future Biochemical Analyzers such as (such as TBA-40FR/120FR).
Matrix effect (Matrix effect): in addition to being measured, sample characteristics of for example is measured particular measurement program determination
And its influence of magnitude.
Quality control (Quality Control): 1) for meeting the operating technology or activity of quality requirement；And/or 2)
To ensure detection system performance, the batch processing of design monitoring analysis method and result.
Specific embodiment
Embodiment
The preparation method of 1. Quality Control substance of embodiment
1. source and the processing of serum matrix
Serum matrix is originated from human serum (being provided by Clinical Institutions or blood donation station)；Optionally, conventionally right
Human serum carries out innoxious pretreatment, to avoid environmental pollution and transmission.Serum matrix is not limited to finally be originated from same next
Source (such as same mammalian subject), can be the mixing of multiple experimenter's serums.
Any one of selected from the following or combination: HIV1 is presented in (such as, but not limited to colloidal gold method) after tested, serum matrix
Negative antibody, HIV2 negative antibody, Hepatitis B Surface antigen feminine gender, hepatitis C virus negative antibody.Herein described " feminine gender " is
Refer to the horizontal presence that determinand can't detect with detection method；Or it is completely absent.
2. the preparation of Quality Control substance
(1) use commercial reagent box and known method, test serum matrix in each determinand (cholesterol, triglycerides,
High-density lipoprotein cholesterol, Apolipoprotein A1, apolipoprotein B, lipoprotein (a), optionally carries low density lipoprotein cholesterol
Lipoprotein E, optionally phosphatide, optionally homocysteine, optionally c reactive protein, optionally small and dense low-density lipoprotein
White cholesterol), tentatively to understand its content situation.
When preparing Quality Control substance, according to preset low value or high level concentration range, allow that difference will be originated from as needed
The serum matrix in source (as being originated from different Clinical Institutions or being purchased from different retailers) mixes, so that final gained mixed
The concentration of each determinand falls into expected concentration range in serum matrix.
In some cases, allow to introduce a certain amount of cholesterol, triglycerides, high density into serum matrix as needed
Lipoprotein cholesterol, low density lipoprotein cholesterol, Apolipoprotein A1, apolipoprotein B, lipoprotein (a), apo E, phosphorus
The one or more of rouge, homocysteine, c reactive protein, so that expected from the concentration of each determinand is fallen into serum matrix
Concentration range.
(2) protective agent and preservative are added into serum matrix.
Preferred protective agent sucrose (example), trehalose, BSA final concentration are respectively 80g/L, 100g/L, 20g/L；It is preferred that
Preservative Sodium azide (example), Benzylpenicillin sodium salt, nystatin final concentration be respectively 2g/L, 2g/L, 30 μm of ol/L.
(3) it is to be mixed uniformly after, packing into container save be used as liquid-type Quality Control substance.
3. the assignment of Quality Control substance:
According to method listed in Table, assignment is carried out to Quality Control substance.
The assignment of 1. low value Quality Control substance of table
| Method And Principle | |
| Total cholesterol | CHOD-PAP method |
| Triglycerides | GPO-PAP method |
| High-density lipoprotein cholesterol | Direct method-selection inhibits method |
| Low density lipoprotein cholesterol | Direct method-surfactant removes method |
| Apolipoprotein A1 | Immunoturbidimetry |
| Apolipoprotein B | Immunoturbidimetry |
| Lipoprotein (a) | Immunoturbidimetry |
| Apo E | Immunoturbidimetry |
| Phosphatide | Peroxidase method |
| Homocysteine | Enzyme parameters |
| C reactive protein | Immunoturbidimetry |
| SdLDL-C | Peroxidase method |
The assignment of 2. high level Quality Control substance of table
The preparation method of 2. freeze-dried type Quality Control substance of embodiment
According to conventional method in that art, the Quality Control substance of embodiment 1 is freeze-dried.
Test case
The measurement (drying weight reduction) of 1. water content of test case
Randomly select 3 bottles of freeze-dried powder Quality Control substances of same lot number in the effect phase；Freeze-dried powder is poured into the title dried respectively
It is weighed in measuring bottle, record weighing value, note calculate freeze-dried powder initial mass, and averageThen 105 DEG C of baking ovens are placed it in
It being weighed after being cooled to room temperature in drying basin to after constant weight within middle baking 2 hours, record weighing value, note calculate freeze-dried powder final mass,
And calculate its average valueThe water content of calibration object is calculated as follows:
The measurement of 3. water content of table
2. uniformity test of test case
1. uniformity in bottle: randomly selecting 1 bottle of Quality Control substance, measure 10 times.
2. uniformity between bottle: randomly selecting 10 bottles of Quality Control substances, and random number 1-10, every bottle measures 1 time.
Uniformity in the bottle of 4. low value Quality Control substance of table
Uniformity between the bottle of 5. low value Quality Control substance of table
| CHO | TG | HDL | LDL | APOA1 | APOB | APOE | LP(a) | PL | HCY | CRP | sdLDL | |
| 1st bottle | 3.75 | 1.14 | 1.03 | 2.22 | 111.33 | 65.68 | 2.72 | 13.71 | 1.97 | 19.53 | 1.02 | 22.68 |
| 2nd bottle | 3.8 | 1.16 | 1.01 | 2.22 | 111.33 | 65.1 | 2.84 | 13.74 | 1.91 | 19.2 | 1.03 | 23.26 |
| 3rd bottle | 3.75 | 1.15 | 1.04 | 2.22 | 111.02 | 64.95 | 2.8 | 13.82 | 1.96 | 19.14 | 1.03 | 21.66 |
| 4th bottle | 3.77 | 1.15 | 1.03 | 2.22 | 110.71 | 64.95 | 2.84 | 13.8 | 1.96 | 19.2 | 1.04 | 22.29 |
| 5th bottle | 3.66 | 1.14 | 1.04 | 2.24 | 110.65 | 65.24 | 2.86 | 13.94 | 1.97 | 19.7 | 1.04 | 22.9 |
| 6th bottle | 3.77 | 1.15 | 1.03 | 2.24 | 111.26 | 65.22 | 2.84 | 13.86 | 1.96 | 19.62 | 1.04 | 22.59 |
| 7th bottle | 3.78 | 1.16 | 1.03 | 2.23 | 111.07 | 64.57 | 2.8 | 13.89 | 1.97 | 19.09 | 1.02 | 22.39 |
| 8th bottle | 3.79 | 1.14 | 1.03 | 2.22 | 111.48 | 65.47 | 2.84 | 13.41 | 1.95 | 19.65 | 1.04 | 22.22 |
| 9th bottle | 3.72 | 1.15 | 1.03 | 2.21 | 112.09 | 64.32 | 2.9 | 13.83 | 1.95 | 19.39 | 1.03 | 22.65 |
| 10th bottle | 3.76 | 1.14 | 1.03 | 2.22 | 110.37 | 64.82 | 2.85 | 13.85 | 1.94 | 19.59 | 1.03 | 22.73 |
| Average value | 3.76 | 1.15 | 1.03 | 2.22 | 111.13 | 65.03 | 2.83 | 13.79 | 1.95 | 19.41 | 1.03 | 22.54 |
| SD | 0.04 | 0.01 | 0.01 | 0.01 | 0.49 | 0.40 | 0.05 | 0.15 | 0.02 | 0.23 | 0.01 | 0.43 |
| Between S bottles | 0.00 | 0.00 | 0.00 | 0.02 | 0.75 | 0.43 | 0.00 | 0.08 | 0.00 | 0.24 | 0.00 | 0.00 |
| CT | 0.00% | 0.00% | 0.00% | 1.08% | 0.68% | 0.66% | 0.00% | 0.58% | 0.00% | 1.23% | 0.29% | 0.00% |
Uniformity in the bottle of 6. high level Quality Control substance of table
Uniformity between the bottle of 7. high level Quality Control substance of table
| CHO | TG | HDL | LDL | APOA1 | APOB | APOE | LP(a) | PL | HCY | CRP | sdLDL | |
| 1st bottle | 6.14 | 1.87 | 1.73 | 3.71 | 183.6 | 102.95 | 4.69 | 21.63 | 3.21 | 38.14 | 2.63 | 56.44 |
| 2nd bottle | 6.07 | 1.8 | 1.75 | 3.74 | 184.45 | 104.33 | 4.83 | 21.72 | 3.23 | 38.26 | 2.63 | 57.72 |
| 3rd bottle | 6.13 | 1.86 | 1.73 | 3.68 | 183.5 | 103.51 | 4.79 | 21.14 | 3.16 | 37.57 | 2.64 | 58.12 |
| 4th bottle | 6.19 | 1.86 | 1.73 | 3.67 | 185.74 | 104.47 | 4.81 | 21.67 | 3.21 | 37.28 | 2.55 | 57.08 |
| 5th bottle | 6.09 | 1.85 | 1.72 | 3.67 | 184.35 | 104.4 | 4.8 | 22.06 | 3.2 | 38.26 | 2.62 | 56.95 |
| 6th bottle | 5.93 | 1.85 | 1.73 | 3.72 | 181.85 | 103.31 | 4.77 | 21.67 | 3.2 | 38.03 | 2.57 | 54.88 |
| 7th bottle | 6.1 | 1.81 | 1.72 | 3.7 | 182.35 | 104.69 | 4.72 | 21.9 | 3.18 | 38.26 | 2.56 | 57.06 |
| 8th bottle | 5.96 | 1.84 | 1.71 | 3.68 | 185.7 | 102.58 | 4.86 | 21.96 | 3.2 | 37.63 | 2.59 | 56.71 |
| 9th bottle | 6.06 | 1.83 | 1.73 | 3.75 | 184.1 | 102.9 | 4.75 | 21.57 | 3.18 | 37 | 2.61 | 57.55 |
| 10th bottle | 6.08 | 1.82 | 1.73 | 3.67 | 183.03 | 103.79 | 4.81 | 21.2 | 3.17 | 37.74 | 2.55 | 55.04 |
| Average value | 6.08 | 1.84 | 1.73 | 3.70 | 183.87 | 103.69 | 4.78 | 21.65 | 3.19 | 37.82 | 2.60 | 56.76 |
| SD | 0.08 | 0.02 | 0.01 | 0.03 | 1.28 | 0.75 | 0.05 | 0.30 | 0.02 | 0.45 | 0.04 | 1.07 |
| Between S bottles | 0.00 | 0.00 | 0.00 | 0.00 | 0.41 | 0.00 | 0.03 | 0.00 | 0.03 | 0.00 | 0.04 | 0.00 |
| CV | 0.00% | 0.00% | 0.00% | 0.00% | 0.22% | 0.00% | 0.55% | 0.00% | 1.02% | 0.00% | 1.55% | 0.00% |
3. freeze-thaw stability of test case
It will be lyophilized after Quality Control material balance to environment temperature (18 to 30 DEG C)；It is careful to open bottle stopper；According to Quality Control substance
Label explanation, is accurately added deionized water；It covers bottle stopper and stands 10 to 40 minutes；It gently overturns and rotating keeps content completely molten
It solves and is uniformly mixed, avoid generating foam.
3 freeze-drying Quality Control substances are taken, will carefully open bottle stopper after Quality Control material balance to room temperature.It is accurate be added 3mL go from
Sub- water covers bottle stopper and stands 30 minutes, gently overturns and rotating bottle makes content be completely dissolved and be uniformly mixed.Freeze thawing one
It is secondary, i.e., it places after room temperature is completely dissolved and detects again after Quality Control substance being placed in -20 DEG C for 24 hours；Freeze thawing twice, i.e., by Quality Control
Substance is placed after being placed in -20 DEG C for 24 hours again after room temperature is completely dissolved, then places -20 DEG C for 24 hours, then is placed after room temperature is completely dissolved
It is detected, and so on.
8. low value freeze-thaw stability of table
9. high level freeze-thaw stability of table
Test case 4. redissolves stability (in 4 DEG C)
The Quality Control substance saved under the conditions of 2 DEG C to 8 DEG C after redissolution chooses no less than five within corresponding stationary phase
Time point uses the kit within the effect phase and the calibration of mating calibration object at every point of time, measures 1 bottle of Quality Control substance, repeat
Measurement 3 times.
4 ° of stability of corkage of 10. low value Quality Control substance of table
4 DEG C of stability of corkage of 11. high level Quality Control substance of table
5. accelerated stability of test case
The Quality Control substance saved under the conditions of 37 DEG C is chosen within corresponding stationary phase and is no less than 5 time points, every
A time point using within the effect phase kit and the calibration of mating calibration object, measure 1 bottle of Quality Control substance, replication 3 times.
The accelerated stability of 12. low value Quality Control substance of table
The accelerated stability of 13. high level Quality Control substance of table
Test case 6. redissolves stability (in -20 DEG C)
The Quality Control substance saved under the conditions of -25 DEG C to -15 DEG C after redissolution, within corresponding stationary phase, selection is no less than
Five time points use the kit within the effect phase and the calibration of mating calibration object at every point of time, measure 1 bottle of Quality Control substance,
Replication 3 times.
14. low value Quality Control -20 DEG C of stability of substance of table
| Control | 4 days | 10 days | 14 days | 16 days | 21 days | 28 days | 31 days | |
| CHO | 3.61 | 0.02 | -0.003 | 0.0117 | 0.0126 | 0.008 | 0.0135 | 0.0052 |
| TG | 1.21 | 0.032 | 0.0101 | 0.0183 | 0.0128 | 0.0156 | 0.0238 | 0.0128 |
| HDL | 1.01 | 0.0287 | -0.004 | 0.0154 | 0.0022 | 0.0187 | 0.0154 | 0.0254 |
| LDL | 2.01 | 0.0282 | -0.005 | 0.0066 | 0.0083 | 0.0066 | 0.0083 | 0.0083 |
| APOA1 | 120.93 | 0.0186 | -0.002 | 0.0032 | 0.0101 | 0.0144 | 0.0108 | 0.0167 |
| APOB | 68.19 | 0.0223 | -0.012 | 0.0028 | -0.003 | 0.0028 | 0 | -0.007 |
| APOE | 2.33 | -0.005 | -0.016 | -0.002 | -0.012 | 0.001 | -0.018 | -0.033 |
| LP(a) | 10.72 | 0.0102 | 0.0043 | -0.004 | 0.0033 | -0.0007 | 0.0077 | 0.0008 |
| PL | 2.02 | 0.0237 | -0.006 | 0.0121 | 0.0072 | 0.0088 | 0.0088 | 0.0171 |
| HCY | 17.5 | 0.0293 | -0.005 | 0.0108 | -0.002 | -0.0062 | 0.0051 | -0.033 |
| CRP | 0.71 | 0.0187 | -0.005 | 0 | -0.005 | 0.014 | 0.014 | 0.014 |
| sdLDL | 19.78 | 0.0285 | -0.042 | -0.024 | -0.043 | -0.0408 | -0.053 | -0.047 |
15. high level Quality Control -20 DEG C of stability of substance of table
| Control | 4 days | 10 days | 14 days | 16 days | 21 days | 28 days | 31 days | |
| CHO | 6.05 | 0.009 | -0.011 | 0.0123 | -0.008 | 0.0029 | 0.0167 | 0.0002 |
| TG | 2.02 | 0.0187 | 0.0088 | 0.032 | -0.001 | 0.0187 | 0.0336 | 0.0138 |
| HDL | 1.77 | 0.0151 | -0.011 | 0.0057 | -0.008 | 0.0151 | 0.0208 | 0.0132 |
| LDL | 3.5 | 0.0117 | -0.012 | 0.006 | -0.014 | 0.0022 | 0.0098 | -0.0006 |
| APOA1 | 199.54 | 0.0118 | -0.007 | 0.0019 | -0.007 | 0.0114 | 0.01 | 0.0065 |
| APOB | 111.5 | -0.004 | -0.026 | -0.017 | -0.021 | -0.006 | 0.0006 | -0.0028 |
| APOE | 3.81 | -0.005 | -0.054 | -0.017 | -0.017 | -0.013 | -0.001 | -0.009 |
| LP(a) | 16.36 | 0.0022 | -0.018 | 0.0214 | -0.008 | 0.0094 | 0.0308 | 0.0039 |
| PL | 3.41 | 0.0091 | -0.005 | 0.0062 | -0.007 | 0.013 | 0.016 | 0.0091 |
| HCY | 47.11 | 0.0048 | -0.005 | -0.002 | -0.009 | 0.0047 | 0.0038 | 0.0042 |
| CRP | 2.19 | 0.0061 | 0 | 0.0091 | -0.003 | 0.003 | 0.0198 | 0.0137 |
| sdLDL | 59.11 | 0.0096 | -0.044 | -0.008 | -0.03 | -0.01 | -0.012 | -0.0162 |
7. visual examination of test case
Quality Control substance prepared by embodiment 1 to 2 is faint yellow or yellow freeze-dried powder, is faint yellow after redissolution or yellow liquid
Body.Visually inspect no any precipitating and cotton-shaped suspended matter.
When protective agent is trehalose or BSA, and preservative is penicillin or nystatin, the result suboptimum of above-mentioned test
(data are not shown).
Claims (9)
1. a kind of composition, it includes:
Serum matrix；
Preferably, the composition is free of polyethylene glycol and Triton-X100.
2. a kind of composition, it includes:
Serum matrix；
Preferably, the composition is free of polyethylene glycol and Triton-X100.
3. composition according to claim 1 or 2, in which:
The protective agent is selected from: sucrose, trehalose, BSA, EDETATE SODIUM, glycine；
Preferably, the protective agent is selected from: sucrose, trehalose, BSA；
The preservative is selected from: Sodium azide, Benzylpenicillin sodium salt, nystatin, gentamicin, proclin 300.
4. composition according to claim 1 or 2, in which:
The serum matrix is originated from people；
Optionally, the serum matrix is presented any one of selected from the following or combination: HIV1 negative antibody, HIV2 negative antibody,
Hepatitis B Surface antigen feminine gender, hepatitis C virus negative antibody.
5. composition according to claim 1 or 2, the composition is liquid form or its dry powder form；Preferably, institute
Stating dry powder is freeze-dried powder.
6. the water content of composition according to claim 5, the freeze-dried powder is no more than 5%；Preferably more than 3%；More
Preferably more than 2%；Most preferably not more than 1.7%.
7. a kind of kit, it includes:
Composition described in claim 1；And/or
Composition as claimed in claim 2.
8. purposes of the composition of any of claims 1 or 2 in preparation Quality Control substance；
Preferably, composition described in claim 1 is preparing the purposes in low value Quality Control substance；
Preferably, purposes of the composition as claimed in claim 2 in preparation high level Quality Control substance.
9. purposes according to claim 8, the Quality Control substance is the Quality Control substance of lipids detection.
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| CN117554151A (en) * | 2024-01-11 | 2024-02-13 | 复星诊断科技(长沙)有限公司 | Cholesterol quality control liquid and preparation method thereof |
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